The Recall Desk
HighFDA (Devices)·Z-0580-2016·Announced 2016-01-13

Corflex Post-Operative Knee Brace Recalled for Potential Locking Failure

Corflex is recalling 80 post-operative knee braces that may fail to maintain the locked position, potentially causing loss of balance or undesired knee movement.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where the brace may fail to maintain a locked position, potentially causing loss of balance or undesired movement, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Corflex is recalling 80 units of the Contender Post-Op-Knee Brace Full Foam (Model 75-7550-000). The recall involves specific units identified by revision codes beginning with AN, AP, AQ, AR, AS, AT, or AU, as well as units with revision codes beginning with AM manufactured between September 1, 2015, and November 6, 2015.

The recall was initiated because the knee brace could fail to maintain the locked position. If the brace fails, a loss of balance or undesired flexion or extension may occur at the affected knee joint. The product is indicated for range of motion control following various knee surgeries, including ACL, PCL, MCL, and LCL surgeries, meniscal repairs, and total knee replacements.

The affected braces were distributed nationwide in the United States and internationally to Canada, Taiwan, Singapore, and England. Consumers should immediately return all affected braces to Corflex for review.

The recalled product

Product
CONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures
Manufacturer
Corflex
Affected units
80

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • (1) all braces that begin with a Revision Code of AN
  • AP
  • AQ
  • AR
  • AS
  • AT
  • AU are to be returned to Corflex immediately for review
  • 2015 and November 6
  • 2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Corflex under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →